Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

Last updated: July 25, 2017
Sponsor: Alliance for Clinical Trials in Oncology
Overall Status: Completed

Phase

3

Condition

Lymphoproliferative Disorders

Neoplasms

Pain

Treatment

N/A

Clinical Study ID

NCT00516503
NCCTG-N06CA
NCI-2011-01768
CDR0000560732
  • Ages > 18
  • All Genders

Study Summary

RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy .

PURPOSE: This randomized phase III trial is studying BAK gel to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:>

  • Diagnosis of cancer>

  • Received or currently receiving neurotoxic chemotherapy including, but not limited to, taxanes (e.g., paclitaxel or docetaxel); platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin); vinca alkaloids (e.g., vincristine or vinblastine); or other neurotoxic chemotherapy agents (e.g., bortezomib, lenalidomide, or thalidomide)>

  • Must have pain or symptoms of peripheral neuropathy attributable to chemotherapy for ≥ 1 month>

  • Neuropathy is limited to either hands and/or feet where gel can be applied>

  • Neuropathic pain score of ≥ 4 out of 10 on the numbness/tingling/pain numeric analogue scale>

  • No pre-existing or history of peripheral neuropathy due to any cause other than chemotherapy (e.g., diabetes, alcohol, toxin, heredity)> PATIENT CHARACTERISTICS:>

  • ECOG performance status 0-2>

  • Life expectancy ≥ 4 months>

  • Creatinine ≤ 1.5 times upper limit of normal>

  • Not pregnant or nursing>

  • No ability to bear children defined by 1 of the criteria:>

  • Menopausal (12 months and no menstrual period if natural menopause)>

  • Underwent a hysterectomy and/or oophorectomy>

  • Permanent surgical sterilization (tubal ligation)>

  • Fertile patients must use effective contraception>

  • Able to complete questionnaires independently or with assistance>

  • Able to sign informed consent and understand the nature of a placebo-controlled trial>

  • No history of an allergic reaction to baclofen, amitriptyline hydrochloride, and/or ketamine>

  • No diagnosis of any New York Heart Association class I-IV congestive heart failure>

  • No diagnosis of coronary artery disease including, but not limited to, myocardial infarction, within the past 5 years>

  • No other medical condition that, in the opinion of the treating physician or allied health professional, would make this clinical trial unreasonably hazardous for the patient>

  • No skin abnormalities at the intended application sites (hands and feet) of study gel (i.e., skin breakdown)> PRIOR CONCURRENT THERAPY:>

  • See Disease Characteristics>

  • More than 30 days since prior anticonvulsants, tricyclic antidepressants, monoamine oxidase inhibitor, or other neuropathic pain medication (e.g., carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch or gel, capsaicin cream, or amifostine)>

  • Patients treated with any of these agents for peripheral neuropathy for ≤ 1 week during the past 30 days are eligible provided they are no longer taking the agent>

  • More than 5 years since prior percutaneous transluminal coronary angioplasty or coronary artery bypass graft>

  • Prior heart valve replacement surgery allowed provided patient has fully recovered from the surgery>

  • No concurrent use of study agents other than as specified in the trial>

Study Design

Total Participants: 208
Study Start date:
February 01, 2008
Estimated Completion Date:
January 31, 2010

Study Description

OBJECTIVES Primary

  • Compare the effectiveness of baclofen-amitriptyline hydrochloride-ketamine (BAK) gel versus placebo, in terms of improving sensory neuropathy, in cancer patients with chemotherapy-induced peripheral neuropathy> Secondary>

  • Compare motor and autonomic symptoms and functioning, mood states, pain, and peripheral neuropathy in these patients.

  • Assess the adverse event profile of topical BAK gel.

  • Explore whether topical BAK gel is absorbed systemically. OUTLINE: Patients are stratified according to neurotoxic chemotherapy (active vs non-active), current use of opioids or oral pain medications (yes vs no), pain rating (4-7 vs 8-10), and prior ineffective pharmacologic treatment for peripheral neuropathy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients apply 1 spoonful of baclofen-amitriptyline hydrochloride-ketamine gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.

  • Arm II: Patients apply 1 spoonful of placebo gel topically to each area of pain, numbness, and/or tingling on the feet and/or hands twice daily for 4 weeks.

Some patients in both arms may choose to continue on the active gel or, if on placebo, begin the active gel for an additional 8 weeks off study. Patients complete health, pain, mood, and quality of life questionnaires at baseline and periodically during study. Patients also record adverse symptoms weekly in a Symptom Experience Diary.

Connect with a study center

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona 85259-5499
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Rush-Copley Cancer Care Center

    Aurora, Illinois 60504
    United States

    Site Not Available

  • St. Joseph Medical Center

    Bloomington, Illinois 61701
    United States

    Site Not Available

  • Graham Hospital

    Canton, Illinois 61520
    United States

    Site Not Available

  • Memorial Hospital

    Carthage, Illinois 62321
    United States

    Site Not Available

  • Eureka Community Hospital

    Eureka, Illinois 61530
    United States

    Site Not Available

  • Galesburg Clinic, PC

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Galesburg Cottage Hospital

    Galesburg, Illinois 61401
    United States

    Site Not Available

  • Mason District Hospital

    Havana, Illinois 62644
    United States

    Site Not Available

  • Hopedale Medical Complex

    Hopedale, Illinois 61747
    United States

    Site Not Available

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois 60435
    United States

    Site Not Available

  • McDonough District Hospital

    Macomb, Illinois 61455
    United States

    Site Not Available

  • Moline, Illinois 61265
    United States

    Site Not Available

  • Community Cancer Center

    Normal, Illinois 61761
    United States

    Site Not Available

  • Community Hospital of Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois, PC - Ottawa

    Ottawa, Illinois 61350
    United States

    Site Not Available

  • Cancer Treatment Center at Pekin Hospital

    Pekin, Illinois 61554
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Methodist Medical Center of Illinois

    Peoria, Illinois 61636
    United States

    Site Not Available

  • OSF St. Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Proctor Hospital

    Peoria, Illinois 61614
    United States

    Site Not Available

  • Illinois Valley Community Hospital

    Peru, Illinois 61354
    United States

    Site Not Available

  • Perry Memorial Hospital

    Princeton, Illinois 61356
    United States

    Site Not Available

  • St. Margaret's Hospital

    Spring Valley, Illinois 61362
    United States

    Site Not Available

  • CCOP - Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana 46107
    United States

    Site Not Available

  • Elkhart General Hospital

    Elkhart, Indiana 46515
    United States

    Site Not Available

  • Howard Community Hospital

    Kokomo, Indiana 46904
    United States

    Site Not Available

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana 46350
    United States

    Site Not Available

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana 46360
    United States

    Site Not Available

  • Reid Hospital & Health Care Services

    Richmond, Indiana 47374
    United States

    Site Not Available

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Memorial Hospital of South Bend

    South Bend, Indiana 46601
    United States

    Site Not Available

  • Saint Joseph Regional Medical Center

    South Bend, Indiana 46617
    United States

    Site Not Available

  • McFarland Clinic, PC

    Ames, Iowa 50010
    United States

    Site Not Available

  • Bettendorf, Iowa 52722
    United States

    Site Not Available

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa 52403
    United States

    Site Not Available

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • St. Luke's Regional Medical Center

    Sioux City, Iowa 51104
    United States

    Site Not Available

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan 49221
    United States

    Site Not Available

  • Haematology-Oncology Associates of Ohio and Michigan, PC

    Lambertville, Michigan 48144
    United States

    Site Not Available

  • Community Cancer Center of Monroe

    Monroe, Michigan 48162
    United States

    Site Not Available

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan 48162
    United States

    Site Not Available

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan 49085
    United States

    Site Not Available

  • Lakeland Regional Cancer Care Center - St. Joseph

    St. Joseph, Michigan 49085
    United States

    Site Not Available

  • MeritCare Bemidji

    Bemidji, Minnesota 56601
    United States

    Site Not Available

  • Fairview Ridges Hospital

    Burnsville, Minnesota 55337
    United States

    Site Not Available

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota 55433
    United States

    Site Not Available

  • CCOP - Duluth

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Duluth Clinic Cancer Center - Duluth

    Duluth, Minnesota 55805-1983
    United States

    Site Not Available

  • Miller - Dwan Medical Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Fairview Southdale Hospital

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Immanuel St. Joseph's

    Mankato, Minnesota 56002
    United States

    Site Not Available

  • Minnesota Oncology Hematology, PA - Maplewood

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

    Robbinsdale, Minnesota 55422-2900
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Park Nicollet Cancer Center

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • United Hospital

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Ridgeview Medical Center

    Waconia, Minnesota 55387
    United States

    Site Not Available

  • Willmar Cancer Center at Rice Memorial Hospital

    Willmar, Minnesota 56201
    United States

    Site Not Available

  • Minnesota Oncology Hematology, PA - Woodbury

    Woodbury, Minnesota 55125
    United States

    Site Not Available

  • Billings Clinic - Downtown

    Billings, Montana 59107-7000
    United States

    Site Not Available

  • CCOP - Montana Cancer Consortium

    Billings, Montana 59101
    United States

    Site Not Available

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana 59101
    United States

    Site Not Available

  • Northern Rockies Radiation Oncology Center

    Billings, Montana 59101
    United States

    Site Not Available

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana 59101
    United States

    Site Not Available

  • St. James Healthcare Cancer Care

    Butte, Montana 59701
    United States

    Site Not Available

  • Big Sky Oncology

    Great Falls, Montana 59405-5309
    United States

    Site Not Available

  • Great Falls Clinic - Main Facility

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Great Falls, Montana 59405
    United States

    Site Not Available

  • Glacier Oncology, PLLC

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Kalispell Regional Medical Center

    Kalispell, Montana 59901
    United States

    Site Not Available

  • Community Medical Center

    Missoula, Montana 59801
    United States

    Site Not Available

  • Guardian Oncology and Center for Wellness

    Missoula, Montana 59804
    United States

    Site Not Available

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana 59807
    United States

    Site Not Available

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana 59807-7877
    United States

    Site Not Available

  • Cancer Resource Center - Lincoln

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Alegant Health Cancer Center at Bergan Mercy Medical Center

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska 68106
    United States

    Site Not Available

  • Creighton University Medical Center

    Omaha, Nebraska 68131-2197
    United States

    Site Not Available

  • Immanuel Medical Center

    Omaha, Nebraska 68122
    United States

    Site Not Available

  • Rutherford Hospital

    Rutherfordton, North Carolina 28139
    United States

    Site Not Available

  • Bismarck Cancer Center

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota 58502
    United States

    Site Not Available

  • CCOP - MeritCare Hospital

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • MeritCare Broadway

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • Altru Cancer Center at Altru Hospital

    Grand Forks, North Dakota 58201
    United States

    Site Not Available

  • Mary Rutan Hospital

    Bellefontaine, Ohio 43311
    United States

    Site Not Available

  • Wood County Oncology Center

    Bowling Green, Ohio 43402
    United States

    Site Not Available

  • Adena Regional Medical Center

    Chillicothe, Ohio 45601
    United States

    Site Not Available

  • North Coast Cancer Care - Clyde

    Clyde, Ohio 43410
    United States

    Site Not Available

  • CCOP - Columbus

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Doctors Hospital at Ohio Health

    Columbus, Ohio 43228
    United States

    Site Not Available

  • Grant Medical Center Cancer Care

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Mount Carmel Health - West Hospital

    Columbus, Ohio 43222
    United States

    Site Not Available

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio 43214-3998
    United States

    Site Not Available

  • CCOP - Dayton

    Dayton, Ohio 45429
    United States

    Site Not Available

  • Good Samaritan Hospital

    Dayton, Ohio 45406
    United States

    Site Not Available

  • Grandview Hospital

    Dayton, Ohio 45405
    United States

    Site Not Available

  • Samaritan North Cancer Care Center

    Dayton, Ohio 45415
    United States

    Site Not Available

  • Grady Memorial Hospital

    Delaware, Ohio 43015
    United States

    Site Not Available

  • Hematology Oncology Center

    Elyria, Ohio 44035
    United States

    Site Not Available

  • Blanchard Valley Medical Associates

    Findlay, Ohio 45840
    United States

    Site Not Available

  • Middletown Regional Hospital

    Franklin, Ohio 45005-1066
    United States

    Site Not Available

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Fairfield Medical Center

    Lancaster, Ohio 43130
    United States

    Site Not Available

  • Lima Memorial Hospital

    Lima, Ohio 45804
    United States

    Site Not Available

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio 45750
    United States

    Site Not Available

  • Northwest Ohio Oncology Center

    Maumee, Ohio 43537
    United States

    Site Not Available

  • St. Luke's Hospital

    Maumee, Ohio 43537
    United States

    Site Not Available

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio 43055
    United States

    Site Not Available

  • St. Charles Mercy Hospital

    Oregon, Ohio 43616
    United States

    Site Not Available

  • Toledo Clinic - Oregon

    Oregon, Ohio 43616
    United States

    Site Not Available

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio 44870
    United States

    Site Not Available

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio 45505
    United States

    Site Not Available

  • Mercy Medical Center

    Springfield, Ohio 45504
    United States

    Site Not Available

  • Flower Hospital Cancer Center

    Sylvania, Ohio 43560
    United States

    Site Not Available

  • Mercy Hospital of Tiffin

    Tiffin, Ohio 44883
    United States

    Site Not Available

  • CCOP - Toledo Community Hospital

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Medical University of Ohio Cancer Center

    Toledo, Ohio 43614
    United States

    Site Not Available

  • St. Anne Mercy Hospital

    Toledo, Ohio 43623
    United States

    Site Not Available

  • St. Vincent Mercy Medical Center

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio 43623
    United States

    Site Not Available

  • Toledo Hospital

    Toledo, Ohio 43606
    United States

    Site Not Available

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio 45373-1300
    United States

    Site Not Available

  • Fulton County Health Center

    Wauseon, Ohio 43567
    United States

    Site Not Available

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio 43081
    United States

    Site Not Available

  • Clinton Memorial Hospital

    Wilmington, Ohio 45177
    United States

    Site Not Available

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio 45385
    United States

    Site Not Available

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio 43701
    United States

    Site Not Available

  • Legacy Mount Hood Medical Center

    Gresham, Oregon 97030
    United States

    Site Not Available

  • Providence Milwaukie Hospital

    Milwaukie, Oregon 97222
    United States

    Site Not Available

  • Adventist Medical Center

    Portland, Oregon 97216
    United States

    Site Not Available

  • CCOP - Columbia River Oncology Program

    Portland, Oregon 97225
    United States

    Site Not Available

  • Legacy Emanuel Hospital and Health Center and Children's Hospital

    Portland, Oregon 97227
    United States

    Site Not Available

  • Legacy Good Samaritan Hospital & Comprehensive Cancer Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon 97213-2967
    United States

    Site Not Available

  • Providence St. Vincent Medical Center

    Portland, Oregon 97225
    United States

    Site Not Available

  • Legacy Meridian Park Hospital

    Tualatin, Oregon 97062
    United States

    Site Not Available

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania 17822-0001
    United States

    Site Not Available

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania 18201
    United States

    Site Not Available

  • Guthrie Cancer Center at Guthrie Clinic Sayre

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania 16801
    United States

    Site Not Available

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania 18711
    United States

    Site Not Available

  • Mercy Hospital at Wilkes-Barre

    Wilkes-Barre, Pennsylvania 18765
    United States

    Site Not Available

  • AnMed Cancer Center

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Rapid City Regional Hospital

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Sanford Cancer Center at Sanford USD Medical Center

    Sioux Falls, South Dakota 57117-5039
    United States

    Site Not Available

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia 22401
    United States

    Site Not Available

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington 98668
    United States

    Site Not Available

  • Franciscan Skemp Healthcare - La Crosse Campus

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

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